ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results
Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a diagnostic device where incorrect patient results may be reported without alerting clinicians. No reported illnesses or injuries, but the potential for diagnostic error and patient harm is significant.
Plain-English summary
The ADVIA Chemistry XPT Chemistry System is an automated clinical chemistry analyzer manufactured by Siemens Healthcare Diagnostics, Inc. It performs diagnostic tests on blood serum, plasma, urine, and cerebrospinal fluid samples. Approximately 842 units have been distributed worldwide, including in the United States and numerous international locations.
Siemens is recalling units with software version 1.4 or lower due to a mixer failure detection issue. The default failure detection setting is configured at level 2. This setting may not align with customer expectations, and if the mixer fails, the system may report erroneous patient results without providing any alert to laboratory staff, potentially resulting in incorrect diagnostic information being delivered to clinicians.
This defect could affect patient care if incorrect lab results are used for diagnosis or treatment decisions. Laboratories and healthcare facilities with affected systems should verify their software version and contact Siemens Healthcare Diagnostics for guidance on proper configuration adjustment or software updates.
The recalled product
- Product
- The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 842
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version: 1.4 or lower UDI - 00630414595467
Distribution
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